510(k) Report

Devices descending from K993106

728 later devices reach Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+4K230527WishBone Medical Plate and Screw SystemWishbone Medical, Inc.20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K202326BESPA Charcot SystemBespa Global, LLC20210—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+4K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+4K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+4K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.20210—
+4K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+4K200062Foot and Ankle SystemLeith Medical, LLC20210—
+4K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K193368Smart Correction SystemWishbone Medical, Inc.202031
+4K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K193029Conquest FNSmith & Nephew, Inc.202010—
+4K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+4K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+4K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+4K190430OsteoCentric Bone Plate and Screw SystemOsteocentric Trauma20192—
+4K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC20181—
+4K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K172350AxSOS 3 TiStryker GmbH201717—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+4K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+4K170727VariAx 2 Compression Plating SystemStryker GmbH20172—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K162380Locking Plate SystemBeijing Keyi Medical Device Technology Co., Ltd.20170—
+4K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K170310Alians Clavicle rangeNewclip Technics20170—
+4K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+4K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+4K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+4K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+4K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+4K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+4K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+4K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K151508IRENE Locking Compression Plate SystemTianjin Zhengtian Medical Instrument Co., Ltd.20160—
+4K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+4K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+4K153378Monster BITE Screw SystemParagon 28201522—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+4K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K142581APTUS Foot SystemMedartis AG201522—
+4K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+4K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+4K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+4K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+4K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153